A Phase 2, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of the New Liquid Formulation of Novartis Meningococcal C Conjugate Vaccine and of the Novartis Lyophilized Meningococcal C Conjugate Vaccine Manufactured at Two Different Sites, in Healthy Toddlers

Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV.

Immunogenicity was measured by hSBA GMTs against N meningitidis type C, approximately 28 days (at day 29) after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM ROS.

Number Of Subjects Reporting Solicited Local And Systemic Adverse Events [ Time Frame: From day 1 through day 7 ] [ Designated as safety issue: Yes ]

Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following a single injection with either MenC-CRM LIQ or MenC-CRM ROS or MenC-CRM EMV.

Safety was also assessed in subjects who mistakenly received MenC-CRM EMV instead of MenC-CRM ROS.

History of severe allergic reaction after previous vaccinations, allergy to Latex, or hypersensitivity to any component of the vaccine.

Significant acute or chronic infection within the previous 7 days or axillary temperature ≥38.0°C within the previous 3 days.

Individuals who have received antibiotics within 6 days before vaccination.

Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):

Receipt of any immunosuppressive therapy at any time since birth.

Receipt of any immunostimulants at any time since birth.

Receipt of any systemic corticosteroids or chronic use of inhaled high-potency corticosteroids since birth (use of topical corticosteroids administered in limited areas of the body [for example, eczema on knees or face or elbows] is allowed).

Immune deficiency disorder, or known HIV infection.

History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited non-medicated febrile seizure is acceptable).

Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Received any other vaccines within 30 days prior to enrollment or intent to receive any other vaccine during the study (Exception: Inactivated influenza vaccine may be administered up to 15 days prior to study immunization and no less than 15 days after study immunization).

Toddler's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.

Participation in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study during this study.

Family members or household members of site research staff.

History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.

Any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01434680